Medicare coverage of medical devices in the U.S. sometimes is limited to a coverage with evidence development (CED) study, a process that may soon become more stringent. A recent advisory hearing on the CED process suggests that significant changes may be in the making, including a requirement that CED studies more closely reflect the demographic diversity of Medicare beneficiaries at large, a mandate that may force device makers to apply more resources to ensure that CED study enrollments fulfill that mandate.
After issuing three prior complete response letters, the U.S. FDA finally granted approval via the 505(b)(2) NDA pathway to Intelgenx Corp.’s Rizafilm Versafilm to treat acute migraine.
Despite concerns about a limited dataset to study, the urgent need to treat one of the toughest and most deadly infections propelled a U.S. FDA advisory committee to unanimously support the NDA for Entasis Therapeutics Inc.’s sulbactam-durlobactam (Sul-Dur). Sul-Dur, an injectable combination of beta-lactam antibiotic and beta-lactamase inhibitor for treating adults with hospital‐acquired bacterial pneumonia and ventilator‐associated bacterial pneumonia caused by susceptible strains of carbapenem-resistant Acinetobacter baumannii infections, has a May 29 PDUFA date.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Eli Lilly, Horizon, Ips, Minghui, Nicox, NS, Ocumension, Pfizer, Soligenix.
The U.S. FDA has finalized a guidance for class II devices for treatment of peripheral artery disease that excludes drug-coated balloons (DCBs), which are regulated as class III devices. One of the issues the med-tech industry may have with the guidance is that it fails to acknowledge that a device accessory is in some instances exempt from the requirements of the 510(k) program even though the agency has a policy specific to that consideration.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Clearpoint Neuro.
As expected, the serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s disease (AD) dementia, found favor April 14 at the joint meeting of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee.
Manufacturing deficiencies stand in the way of two BLAs as complete response letters (CRLs) were issued to Eli Lilly and Co. and to Alvotech Holdings SA. The U.S. FDA issued the CRL to Lilly regarding the BLA for mirikizumab, a humanized IgG4 monoclonal antibody to treat ulcerative colitis, specifically citing manufacturing concerns. There’s a similar problem with Alvotech’s biosimilar candidate for Abbvie Inc.’s Humira (adalimumab). The FDA issued a CRL for AVT-02’s BLA, citing problems needing resolution at its Reykjavik, Iceland, manufacturing facility before it could approve the application.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allegro, Astrazeneca, Atma, Aviceda, Fusion, Merck & Co., Sab.
Seemingly in response to the release of a proposed rule for ethylene oxide emissions by the U.S. Environmental Protection Agency, the U.S. FDA has released a second pilot program for device master files for sterilization of medical devices. This program is for single-use PMA devices only made by nine companies and allows the manufacturer or sterilizer to document the switch to radiation sterilization with an expedited review process.
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